Study for the Evaluation of Vemurafenib ( Zelboraf® ) and Ipilimumab ( Yervoy® ) in Combination With DNE3 Therapy to Patients With Metastatic Melanoma

• Register: ClinicalTrials.gov
• Last refreshed on: 11 May 2015
• Main ID: NCT02095652
• Date of registration: 17/03/2014
• Prospective Registration: No
• Primary sponsor: Cancer Centre of Monoclonal Therapy, LLC
• Public title: Study for the Evaluation of Vemurafenib ( Zelboraf® ) and Ipilimumab ( Yervoy® ) in Combination With DNE3 Therapy to Patients With Metastatic Melanoma
• Scientific title: Phase 1/2 Study for the Evaluation of Vemurafenib ( Zelboraf® ) and Ipilimumab ( Yervoy® ) in Combination With DNE3 Therapy to Patients With Metastatic Melanoma
• Date of first enrolment: September 2013
• Target sample size: 95
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT02095652
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Belarus, Germany, Russian Federation, Ukraine

Contacts

• Name: Valentina Kolesnik
• Affiliation: Cancer Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Previously untreated, metastatic melanoma with activating V600
Serine/threonine-protein kinase B-Raf (BRAF) mutation

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

Exclusion Criteria:

- Autoimmune disease

- Active Brain Metastases (with symptoms or requiring corticosteroid treatment)

- Prior therapy with immunosuppressive agents (within the past 2 years) and any
anti-cancer therapy

- Active pneumonitis or interstitial lung disease

- Lactating female

- History of another malignancy (Exception: Subjects who have been disease-free for 3
years, or subjects with a history of completely resected non-melanoma skin cancer or
successfully treated in situ carcinoma are eligible)

- Any serious and/or unstable pre-existing medical, psychiatric disorder or other
conditions that could interfere with subject's safety, obtaining informed consent or
compliance to the study procedures

- Any prohibited medication

- Administration of an investigational study treatment within 28 days or 5 half-lives,
whichever is longer, preceding the first dose of study treatment(s) in this study
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to the study treatments, their excipients, and/or dimethyl
sulfoxide (DMSO)

- Unwillingness or inability to follow the procedures outlined in the protocol



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Melanoma

Metastatic Melanoma

Intervention(s)

Drug: Vemurafenib 960 mg tablet by mouth (oral) twice daily

Drug: Ipilimumab 10 mg/kg Intravenous (IV) injection

Biological: DNE3 0.2?g/kg of body weight

Primary Outcome(s)

To assess the safety of DNE3 in combination with Vemurafenib and Ipilimumab and select the optimal dose of DNE3 for the phase II portion in patients with metastasis melanoma (Phase I) [Time Frame: up to approximately 3 years]

Secondary Outcome(s)

Overall survival (Phase II) [Time Frame: From date of registration to date of death due to any cause, assessed up to 5 years]

Secondary ID(s)

PTC-293-72

XTPTC-293-72

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)

Melanoma Research Foundation